Upcoming Execution Tests Trump Administration’s Commitment to Religious Liberty

AUSTIN SARAT

Austin Sarat—Associate Provost, Associate Dean of the Faculty, and William Nelson Cromwell Professor of Jurisprudence and Political Science at Amherst College—comments on a religious liberty issue presented by the upcoming execution of Wesley Ira Purkey. Sarat explains that Purkey’s spiritual advisor is unable to attend Purkey’s execution due to the COVID-19 pandemic, and he points out that for the federal government to carry out the execution anyway would belie its purported commitment to religious liberty.

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Genentech, Inc. v. Immunex Rhode Island Corp.

Docket: 19-2155

Opinion Date: July 6, 2020

Judge: Kimberly Ann Moore

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license application, 42 U.S.C. 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 2017. In October, Amgen notified Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed motions, seeking to preclude Amgen from commercially marketing Mvasi until Amgen “provides notice of its intent to commercially market such product” pursuant to 42 U.S.C. 262(l)(8) and 180 days have elapsed,” arguing that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices. The Federal Circuit affirmed the denial of the motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements.